乳泰胶囊质量标准研究

Study on quality standard of Rutai Capsules

目的研究乳泰胶囊的薄层色谱鉴别和含量测定方法。方法分别采用野黄芩苷、α-香附酮、野菊花为对照鉴别制剂中的半枝莲、香附、野菊花。采用高效液相色谱法测定陈皮、青皮中的有效成分橙皮苷的含量,色谱柱为AgilentTc-C18色谱柱(4.6mm×250mm,5μm),流动相为甲醇-0.025mol/L磷酸溶液(20:80),流速为1.0mL/min,检测波长为283nm,柱温为30℃。结果薄层色谱方法专属性强。橙皮苷线性范围为1.00～8.02μg(r=0.9996),平均回收率为99.06%,RSD为1.15%(n=9)。结论所建立的方法准确,能科学评价乳泰胶囊的质量。

Objective To establish TLC and HPLC for Rutai Capsules. Methods Scutellarin、α-Cyperon and Flos Chrysanthemi were used as reference substance to identify Herba Scutellariae Barbatae 、Rhizoma Cyperi and Flos Chrysanthemi Indici.The content of hesperidin was detected by RP-HPLC, methanol-0.025 mol/L phosphoric acid （20 ∶ 80）was used as mobile phase,the flow velocity was 1.0 mL/min and the detecting wavelength was 283 nm,column temperature was 30 ℃ .Results TLC was specific. The calibration curve for hesperidin was 1.00-8.02 μg（r=0.9996）,with average recovery 99.06% and RSD 1.15%（n=9）. Conclusion The method is accurate and can scientifically evaluate the quality of the preparation .